MalfunctionFIL
FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Mar 22, 2002 · Event occurred Feb 23, 2002
Report 2937457-2002-00021 · MDR key 384469
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Output, high
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT A PATIENT REMOVED TOO MUCH FLUID DURING A HEMODIALYSIS TREATMENT. BASED ON THE REPORTED PRE AND POST WEIGHTS, PATIENT HAD LOST 6.5KG. THE MACHINE INDICATED THAT 3.8 KG. WAS REMOVED. PATIENT WAS GIVEN THREE LITERS OF SALINE TO BRING THEM UP TO THEIR DRY WEIGHT. THE PATIENT WAS ASYMPTOMATIC AND WAS DISCHARGED AMBULATORY AND STABLE.